US20250228706A1

Movatterモバイル変換

Info

Publication number: US20250228706A1
Application number: US18/697,680
Authority: US
Inventors: Katherine Sapozhnikov; Steven Pham; Tessa Bronez; Eric Schultz; David Batten
Original assignee: Shifamed Holdings LLC
Current assignee: Shifamed Holdings LLC
Priority date: 2021-10-13
Filing date: 2022-10-13
Publication date: 2025-07-17
Also published as: WO2023064487A1

Abstract

The present technology is generally directed to shunt delivery systems and associated methods for delivering and deploying adjustable shunts. In some embodiments, the delivery systems include a device that can be easily held and manipulated by a physician or other user during an implant procedure. In some embodiments, the delivery system can be configured to facilitate priming of the adjustable shunt, such as before implantation of the adjustable shunt. In at least some embodiments, for example, the delivery system can include one or more priming ports or apertures fluidly coupled to the intraocular shunting system at least when the delivery system is in the first state. Fluid can be introduced into the delivery system via individual ones of the priming ports and flow toward and/or into the adjustable shunt to thereby “prime” the adjustable shunt.

Description

CROSS-REFERENCE TO RELATED APPLICATION(S)

The present application claims priority to U.S. Provisional Patent Application No. 63/255,383, filed Oct. 13, 2021, and U.S. Provisional Patent Application No. 63/371,848, filed Aug. 18, 2022, the disclosures of which are incorporated by reference herein in their entireties.

TECHNICAL FIELD

The present technology generally relates to systems and methods for delivering and deploying implantable medical devices and, in particular, to delivery systems and associated methods for delivering and deploying intraocular shunts.

BACKGROUND

Implantable shunting systems are widely used to treat a variety of patient conditions by shunting fluid from a first body region/cavity to a second body region/cavity. For example, shunting systems have been proposed for treating glaucoma. The flow of fluid through the shunting systems is primarily controlled by the pressure gradient across the shunt and the physical characteristics of the flow path defined through the shunt (e.g., the resistance of the shunt lumen). Conventional, early shunting systems (sometimes referred to as minimally invasive glaucoma surgery devices or “MIGS” devices) have shown clinical benefit; however, there is a need for improved shunting systems, systems for delivering such shunting systems, and techniques for addressing elevated intraocular pressure and risks associated with glaucoma. For example, there is a need for shunting systems capable of adjusting the therapy provided, including the flow rate between the two fluidly connected bodies. Further, there is a need for delivery systems for effectively and precisely delivering such shunting systems to target treatment locations within patients.

BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily drawn to scale. Instead, emphasis is placed on illustrating clearly the principles of the present technology. Furthermore, components can be shown as transparent in certain views for clarity of illustration only and not to indicate that the component is necessarily transparent. Components may also be shown schematically.

FIGS.1A-1C are perspective, side, and exploded views, respectively, of a delivery system configured for delivery of an adjustable shunting system in accordance with select embodiments of the present technology.

FIGS.2A and2B are side views illustrating operation of the delivery system ofFIGS.1A-1C.

FIGS.3A-3C illustrate various stages of an operation for deploying a shunting system into a human eye using the delivery system ofFIGS.1A-1C in accordance with select embodiments of the present technology.

FIGS.4A-4D are perspective, side, exploded, and enlarged views, respectively, of another delivery system configured for delivery of an adjustable shunting system in accordance with embodiments of the present technology.

FIGS.5A and5B are top views illustrating operation of the delivery system ofFIGS.4A-4D in accordance with embodiments of the present technology.

FIG.6 is a top view illustrating a portion of a priming procedure including the delivery system ofFIGS.3A-3C in accordance with embodiments of the present technology.

FIG.7 is a perspective view of an adjustable shunting system that can be delivered using the delivery system ofFIGS.1A-2C and/orFIGS.4A-6 and configured in accordance with select embodiments of the present technology.

FIGS.8A and8B are perspective views of a priming assembly positioned within the adjustable shunting system ofFIG.7 and configured in accordance with embodiments of the present technology.

FIG.8C is a partially-schematic cross-sectional view of the adjustable shunting system ofFIG.7 and the priming assembly ofFIGS.8A and8B taken along line8C-8C inFIG.8A.

FIG.8D is a partially-schematic cross-sectional view of the adjustable shunting system ofFIG.7 and the priming assembly ofFIGS.8A and8B taken along line8D-8D inFIG.8B.

FIG.9 is a perspective view of another priming assembly configured in accordance with embodiments of the present technology.

DETAILED DESCRIPTION

The present technology is directed to delivery systems and associated methods for delivering and deploying adjustable shunting systems. In some embodiments, the delivery systems include a device that can be easily held and manipulated by a physician or other user during an implant procedure. The delivery systems can include a body, a drive assembly, and a driven assembly. The driven assembly can be operably coupled to the drive assembly, such that movement of the drive assembly can cause corresponding movement of the driven assembly. Additionally, the driven assembly can be operably coupled to an adjustable shunting system configured for implantation within a patient, such that movement of the driven assembly can cause corresponding movement of the adjustable shunting system. In at least some embodiments, for example, the delivery system can be configured to transition between (i) a first state or configuration in which the adjustable shunting system is positioned within the body of the delivery system, and (ii) a second state or configuration in which the adjustable shunting system is positioned outside of and/or extends at least partially beyond the body of the delivery system. A user can rotate the drive assembly to cause linear movement of the driven assembly and cause the delivery system to transition from the first state to and/or toward the second state. With the delivery system in the second state, the delivery system can be used to implant the adjustable shunting system in the patient during the implantation procedure, such as within an eye of the patient.

The terminology used in the description presented below is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific embodiments of the present technology. Certain terms may even be emphasized below; however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section. Additionally, the present technology can include other embodiments that are within the scope of the claims but are not described in detail with respect toFIGS.1A-9.

Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present technology. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features or characteristics may be combined in any suitable manner in one or more embodiments.

As used herein, the use of relative terminology, such as “about”, “approximately”, “substantially” and the like refer to the stated value plus or minus ten percent. For example, the use of the term “about 100” refers to a range of from 90 to 110, inclusive. In instances in which the context requires otherwise and/or relative terminology is used in reference to something that does not include a numerical value, the terms are given their ordinary meaning to one skilled in the art.

Reference throughout this specification to the term “resistance” refers to fluid resistance unless the context clearly dictates otherwise. The terms “drainage rate” and “flow rate” are used interchangeably to describe the movement of fluid through a structure at a particular volumetric rate. The term “flow” is used herein to refer to the motion of fluid, in general.

Although certain embodiments herein are described in terms of shunting fluid from an anterior chamber of an eye, one of skill in the art will appreciate that the present technology can be readily adapted to shunt fluid from and/or between other portions of the eye (including the posterior chamber), or, more generally, from and/or between a first body region and a second body region. Moreover, while the certain embodiments herein are described in the context of glaucoma treatment, any of the embodiments herein, including those referred to as “glaucoma shunts” or “glaucoma devices” may nevertheless be used and/or modified to treat other diseases or conditions, including other diseases or conditions of the eye or other body regions. For example, the systems described herein can be used to treat diseases characterized by increased pressure and/or fluid build-up, including but not limited to heart failure (e.g., heart failure with preserved ejection fraction, heart failure with reduced ejection fraction, etc.), pulmonary failure, renal failure, hydrocephalus, and the like. Moreover, while generally described in terms of shunting aqueous, the systems described herein may be applied equally to shunting other fluid, such as blood or cerebrospinal fluid, between the first body region and the second body region.

FIGS.1A-1C are perspective, side, and exploded views, respectively, of a delivery system100 (“system100”) configured for delivery of an adjustable shunting system in accordance with embodiments of the present technology. Referring toFIGS.1A and1B together, the system100 includes a delivery system body or housing102, a first (e.g., distal) end portion104a,and a second (e.g., proximal) end portion104bopposite the first end portion104a.The housing102 can have a length L of, for example, at least 2 inches, 3 inches, 4 inches, 5 inches, 5.5 inches, 6 inches, 7 inches, any length therebetween, or another suitable length. The housing102 can have a width W of at least, for example, 0.1 inch, 0.2 inch, 0.3 inch, 0.35 inch, 0.375 inch, 0.4 inch, 0.5 inch, 1 inch, any width therebetween, or another suitable width. The system100 can further include a nosecone or tip106 coupled to the housing102 and/or a portion of the housing102 at or near the first end portion104a.The tip106 can define a distal terminus108 of the system100. Additionally, the housing102 and/or the tip106 can be hollow and define a lumen110 extending through the housing102, e.g., between the first and second end portions104a,104b.

The system100 can further include a drive assembly112 and a driven assembly114. The drive assembly112 can include, for example, a drive head116 and a drive shaft118 coupled to and/or extending from the drive head116. In the illustrated embodiment, at least a portion of the drive shaft118 is threaded and configured to threadably engage the housing102 within the lumen110 (e.g., via the second end portion104b). With continued reference to the illustrated embodiment, the drive head116 can be rotated relative to the housing102 to cause the drive shaft118 to move along a longitudinal axis Z of the system100, e.g., in a first direction D1 toward the distal terminus108 and/or in a second direction D2 away from the distal terminus108. In other embodiments, the drive assembly112 can have another suitable configuration. For example, the drive shaft118 can include one or more projections or recesses configured to be slidably received by correspondingly-shaped structures within the housing102.

The driven assembly114 can include a pusher or driven component120. The driven component120 can be operably coupled to the drive shaft118 such that movement of the drive shaft118 causes corresponding movement of the driven component120, e.g., in the first direction D1 and/or the second direction D2. For example, rotational movement of the drive shaft118 that causes the drive shaft118 to move toward the distal terminus108 can also cause the driven component120 to move toward the distal terminus108. In the illustrated embodiment, the driven assembly114 further includes a key or pin122 configured to at least partially prevent rotational movement of the driven component120. The pin122 can be slidably received by a slot124 through the housing102 to thereby inhibit or prevent rotation of the driven component120 relative to the housing102. In the illustrated embodiment, the slot124 can be formed fully-through the housing102, such that the pin122 can extend through the slot124 and protrude radially outward from the housing102. In other embodiments, the slot124 can be formed partially though the housing102, such that the pin122 can be positioned within the housing102. In further embodiments, the pin122 and/or the slot124 can be omitted.

Referring toFIG.1C, the drive shaft118 of the drive assembly112 can include a distal terminus126 configured to contact or otherwise engage at least a portion of the driven assembly114. In some embodiments, the drive shaft118 includes a sealing element128, such as an O-ring, configured to sealing engage with the interior of the housing102. The sealing element128 can be positioned at or near (e.g., proximally from) the distal terminus126. The driven component120 can include a first (e.g., distal) end130aand a second (e.g., proximal) end130bopposite the first end130a.When the system100 is assembled (as shown inFIGS.1A and1B), the second end130bcan be contacted/engaged by a distal terminus126 of the drive assembly112. In at least some embodiments, the distal terminus126 can be positioned within the second end130b.

FIGS.2A and2B are side views illustrating operation of the system100 ofFIGS.1A-1C. More specifically, referring toFIGS.2A and2B together, the drive assembly112 can be actuated (e.g., by a user) to cause movement of the driven assembly114 and transition the system100 between a first state201a(FIG.2A) and a second state201b(FIG.2B). In the illustrated embodiment, for example, a user can rotate the drive head116 in a first rotary direction R1 to cause the drive shaft118 to move in the first direction D1, as shown inFIG.2A. This movement of the drive shaft118 causes corresponding movement of the driven component120 (e.g., in the first direction D1) and thereby transitions the system100 from the first state201atoward and/or to the second state201b,shown inFIG.2B. In the second state201b,the shunt136 can be positioned for insertion/implantation within a patient (not shown). For example, in the second state201b,at least part or all of the shunt136 can be positioned outside of the lumen110 and/or extend beyond (e.g., distally beyond) the distal terminus108 of the system100.

As shown inFIG.2B, the user can transition the system100 from the second state201btoward and/or to the first state201aby rotating the drive head116 in a second rotary direction R2 opposite the first rotary direction R1 to cause the drive shaft118 to move in the second direction D2. This movement of the drive shaft118 can cause corresponding movement of the driven component120 (e.g., in the second direction D2) and thereby transition the system100 from the second state201btoward and/or to the first state201a(FIG.2A). In the first state201a,the shunt136 (shown schematically) can be positioned within (e.g., fully within) the housing102, such that the housing102 can protect or shield the shunt136 from outside interference (e.g., damage, contaminants, particulate matter, and/or the like), such as before and/or during the implantation procedure, transportation, shipping, etc.

FIGS.3A-3C illustrate various stages of an operation for deploying an adjustable shunting system into a patient's eye E using the system100 in accordance with embodiments of the present technology. In a particular example, the system100 can be used to deploy the shunt136 such that, after implantation, the shunt136 is positioned to route fluid from an anterior chamber of the patient's eye E to a suitable outflow location, such as a subconjunctival bleb space (e.g., to treat glaucoma).

Referring first toFIG.3A, one or more tools338 (e.g., a keratome) can be used to make one or more incisions340 in the eye E. Referring next toFIG.3B, the system100 can be transitioned toward and/or to the second state201b(as described above with reference toFIG.2B) and used to insert the shunt136 into the eye E through the incision340. For example, as shown inFIG.3C, the shunt136 can be positioned such that a first or inflow portion336aof the shunt136 is positioned in a first body region and a second or outflow portion336bof the shunt136 is positioned in a second body region. In this way, after implantation, fluid within the first body region can flow/drain through the shunt136 toward and/or into the second body region. In some embodiments, the shunt136 can be configured to assume a curved, bent, or preformed shape during/after implantation in the patient, as shown inFIG.3C. Additionally, or alternatively, the system100 can be configured to adjust the shape of the system100 in situ, and/or one or more of the tools338 can be used to adjust the shape of the system100 in situ.

Although inFIG.3C the first portion336aof the shunt136 is illustrated as being positioned anterior to (e.g., in front of/above) the patient's iris I, in other embodiments the first portion336acan be positioned posterior to (e.g., behind/below) the iris I (also referred to as “sub-iris” positioning). The sub-iris positioning of the shunt136 is expected to reduce or prevent corneal endothelial disease and/or failure, for example, by reducing or preventing disruption to nutrient and/or other fluid and/or chemical transport to and/or through the corneal endothelium. In the illustrated embodiment, the shunt136 is configured to receive fluid (e.g., aqueous) through one or more openings or inlets in an upper surface339aof the shunt136. In these and other embodiments, including when the shunt136 has a sub-iris position, the shunt136 can be configured to receive fluid through one or more lateral openings, e.g., positioned in one or more sides337a,337bof the shunt136, and/or through one or more openings in a bottom surface339bof the shunt136.

In general, the shunt136 can be configured to actuate and/or change its resistance to fluid flow in response to energy (e.g., laser energy) delivered from a source external to the patient. An example of such a configuration is described in detail in U.S. Patent App. Publication No. US 2021/0251806, filed Feb. 12, 2021, and incorporated herein by reference for all purposes. In embodiments in which the shunt136 is positioned sub-iris, the shunt136 can be actuated using a number of techniques. For example, a portion of the iris I can be removed (e.g., iridectomy) to provide line-of-sight access to the shunt136. Additionally, or alternatively, the shunt136 can be positioned such that at least a portion of the shunt136 (e.g., at least part of the first portion336a) can be exposed when the eye E undergoes pupil dilation. In such embodiments, the pupil of the eye E can be dilated and then energy can be delivered to actuate the shunt136. In these and other embodiments, the energy can be targeted using a first energy source (e.g., a first laser) configured to transmit first energy (e.g., targeting energy) at or near a first wavelength to which the iris I is translucent or transparent, and then a same or different energy source can transmit second energy (e.g., actuating energy) at a second wavelength different than the first wavelength.

In some embodiments, the shunt136 can be configured to reduce or prevent cellular growth onto, over, and/or around at least a portion of the shunt136. In at least some embodiments, for example, all or a portion of the shunt136 can include one or more radioisotopes configured to inhibit or prevent cellular growth. The radioisotopes can include Phosporous-32, Strontium-89, Strontium-90, Yttrium-90, and/or another suitable radioisotope. Individual ones of the radioisotopes can emit alpha, beta, and/or gamma radiation, each of which are expected to inhibit or prevent cellular growth on, over, and/or near the shunt136. For a given patient, the radioisotope(s) used with the shunt136 can be selected based at least partially on the half-life of the radioisotope, the type of radiation, and/or the energy of the emitted alpha, beta, and/or gamma particles. The radioisotopes can be naturally-occurring or manufactured (e.g., using a cyclotron, reactor-produced, etc.).

FIG.4A is a perspective view of another delivery system400 (“system400”) configured in accordance with embodiments of the present technology.FIG.4B is a side view of the system400 with select aspects of the system400 illustrated as transparent merely for purposes of illustration. At least some aspects of the system400 can be generally similar or identical in structure and/or function to the system100 ofFIGS.1A-3C. For example, the system400 can be configured to carry the shunt136 (shown schematically inFIG.4A) and/or used to implant the shunt136 within a patient's eye, as described previously herein (e.g., with reference toFIGS.3A-3C). Accordingly, like names and/or reference numbers (e.g., the housing102 versus housing402) are used to indicate generally similar or identical aspects.

Referring toFIGS.4A and4B together, the system400 includes a housing402 having a first (e.g., distal) end portion404a,a second (e.g., proximal) end portion404bopposite the first end portion404a,and a nosecone or tip assembly406 (“tip406”) at or near the first end portion404a.The tip406 can include a slot or opening442 through which an adjustable intraocular shunting system (e.g., the shunt136) can be deployed. In the illustrated embodiment, the tip406 is a separate component configured to be positionable within the housing402 via a slot or opening424 formed therethrough, such that the tip406 can extend through and beyond the distal end portion404aof the housing402. The tip406 can include a key or flange422 configured to extend through the slot424 and thereby at least partially prevent rotational movement of the tip406 relative to the housing402. In other embodiments, the tip406 and the housing402 can together comprise a unitary, single-piece assembly or component.

The system400 can further include a drive assembly412 and a driven assembly414. The drive assembly412 can include a drive head416 and a drive shaft418. The drive shaft418 can be threaded and configured to threadably engage the housing402. During operation, the drive head416 can be rotated to cause the drive shaft418 to move along a longitudinal axis Z of the system100, e.g., in the first direction D1 and/or in the second direction D2. The driven assembly414 can include a pusher or driven component420. The driven component420 can be operably coupled to the drive shaft418 such that movement of the drive shaft418 causes corresponding movement of the driven component420, e.g., in the first direction D1 and/or the second direction D2.

FIG.4C is an exploded top view of the system400. Referring toFIGS.4B and4C together, the drive shaft418 can include a key or protrusion446 (e.g., an annular or radial key/protrusion) configured to be received within a slot or recess448 (e.g., an annular or radial slot/recess) of a coupling channel450 of the driven component420. The protrusion446 and/or the recess448 can be configured to allow the drive assembly412 to rotate (e.g., freely rotate) relative to the driven assembly414 without or substantially without (i) causing corresponding rotational movement of the driven component420 and/or (ii) exerting torque/torsion forces on the driven component420. Accordingly, rotational movement of the drive assembly412 (e.g., relative to the housing402) can cause linear or substantially linear movement of the driven assembly414 (e.g., along the longitudinal axis of the housing402), as described previously herein (e.g., with reference toFIGS.1A-2B). The linear movement of the driven assembly414 can cause a push rod432 to move the shunt136 (FIG.4C) through the tip406, e.g., to deploy the shunt136 from within the system400. The push rod432 can extend through a second or proximal opening443 in the tip406 to contact the shunt136.

Referring again toFIG.4A, the system400 can optionally include a cap or covering component444 configured to be releasably couplable to the system400 and/or positioned around at least a portion of the tip406. The cap444 can at least partially protect the tip406 and/or the shunt136 from damage, e.g., during shipping and/or movement of the system400. The cap444 may be removed, as shown inFIG.4B, as part of a procedure involving the system400 and/or prior to deploying a shunt through the tip406.

FIG.4D is an enlarged view of the cap444 and the tip406, with other aspects of the system omitted for the purpose of clarity. As shown inFIG.4D, the cap444 can include one or more ports452 (which can also be referred to as “priming ports”, “priming inlets”, and/or the like). Individual ones of the ports452 can be fluidly coupled to an interior of the tip406, e.g., via the opening442. In at least some embodiments, for example, the cap444 can define a chamber454 configured to receive at least a portion of the tip406. Fluid (e.g., priming fluid) introduced through one or more of the ports452 can enter the chamber454 and flow into the tip406 via the opening442. The fluid can be drawn through one or more of the ports452, such as in response to a reduced pressure or vacuum generated within the chamber454, injected through one or more of the ports452, such as using a syringe or other fluid delivery tool, and/or another suitable fluid delivery technique. As described in further detail below with reference toFIG.6, the fluid introduced via the ports452 can be used to prime a shunt (e.g., shunt136) carried by the system400. The cap444 can be configured to form a substantially fluid-impermeable seal455 with at least a portion of the tip406, such that all or substantially all fluid flow into and/or out of the chamber454 is through one or more of the ports452 and/or the tip406.

FIGS.5A and5B are side views illustrating operation of the system400 ofFIGS.4A-4D. Referring toFIGS.5A and5B together, the drive assembly412 can be actuated (e.g., by a user) to cause movement of the driven assembly414 and transition the system400 between a first state501a(FIG.5A) and a second state501b(FIG.5B). In the illustrated embodiment, for example, when a user rotates the drive head416 in a first rotary direction R1, the drive shaft418 moves in the first direction D1 (as shown inFIG.5A). As noted previously, this movement of the drive shaft418 results in corresponding movement of the driven component420 and/or the push rod432 (e.g., in the first direction D1), thereby transitioning the system400 from the first state501atoward and/or to the second state501b(as shown inFIG.5B). In the second state501b,the shunt136 is positioned for insertion/implantation within a patient. For example, in the second state501b,at least part or all of the shunt136 can be positioned outside of the tip406, e.g., outside of and/or distally beyond the opening442 (FIG.5A).

The system400 can be transitioned from the second state501btoward and/or to the first state501aby rotating the drive head416 in a second rotary direction R2 opposite the first rotary direction R1 to cause the drive shaft418 to move in the second direction D2, as shown inFIG.2B. This movement of the drive shaft418 results in corresponding movement of the driven component420 (e.g., in the second direction D2), thereby transitioning the system400 from the second state501btoward and/or to the first state501a,shown inFIG.5A. As noted previously, in the first state501a,the shunt136 is positioned within (e.g., fully within) the tip406 and accordingly protected/shielded from outside interference (e.g., damage, contaminants, particulate matter, etc.).

FIG.6 is a top view of the system400 during a priming procedure in accordance with embodiments of the present technology. In some embodiments, the shunt136 is primed before implantation. Priming the shunt136 can include introducing fluid (e.g., priming fluid) into at least a portion of the shunt136 to thereby reduce resistance to initiating fluid flow through the shunt136, e.g., after the shunt136 has been implanted. In the illustrated embodiment, for example, a fluid delivery tool656, such as a syringe, is loaded with priming fluid658 and used to flow/inject the priming fluid658 into the chamber454 of the cap444 via one or more of the ports452 (three labeled inFIG.6). Once within the chamber454, the priming fluid658 can flow into the shunt136 via the opening442 in the tip406. For example, the force/pressure generated by the fluid delivery tool656 and with which the priming fluid658 is injected into the chamber454 can be greater than a fluid inflow resistance of the shunt136, such that all or part of the priming fluid658 is expected to flow into the shunt136. Additionally, or alternatively, injecting fluid into the chamber454 can create a pressure gradient between the chamber454 and the interior of the shunt136; the pressure gradient can exceed the fluid inflow resistance of the shunt136 and cause all or part of the priming fluid658 to flow into the shunt136.

In these and other embodiments, the priming fluid658 can be introduced through the second opening443 of the tip406. For example, the drive assembly412 can be rotated in the second rotary direction R2 to transition the system400 to a third or priming state601cin which the push rod432 (shown schematically) is not positioned within and/or spaced apart from the second opening443, and/or the driven assembly414 (shown schematically) is not positioned within and/or is positioned proximally from the slot424, as shown inFIG.6. Retracting the push rod432 from the second opening443 of the tip406 can allow the priming fluid658 to be introduced into the tip406 via the second opening443. In some embodiments, priming the shunt136 can include introducing the priming fluid658 via the second opening443 until at least a portion of the priming fluid658 flows through the shunt136, into the chamber454, and/or out of the cap444 through one or more of the ports452. Additionally, or alternatively, priming the shunt136 can include introducing the priming fluid658 through individual ones of the ports452 until at least a portion of the priming fluid658 flows into the tip406 via the opening442, through shunt136, toward the second opening443, and/or out of tip406 via the second opening443.

FIG.7 is a perspective view of the shunt136. The shunt136 can include a plate or flow control assembly760 configured to provide adjustable resistance to fluid (e.g., aqueous) flow through the shunt136. The flow control assembly760 can include an interface portion762 that fluidly couples the flow control assembly760 to an outflow channel764 and a fluid outlet766 of the shunt136. In some embodiments, the shunt136 can be configured to receive fluid via the first end portion336a,such that fluid can flow through the shunt136 from the flow control assembly760 toward and/or to the outflow channel764 and/or out of the shunt136 through the second portion336b.Additionally, or alternatively, the shunt136 can be configured to receive fluid via the second portion336b,such that fluid can flow through the shunt136 from the outflow channel764 toward and/or to flow control assembly760 and/or out of the shunt136 through the first portion336a.In some embodiments, the direction of fluid flow through the shunt can be based at least partially on the relative positions of the first and second portions336a,336b,as described previously herein (e.g., with reference toFIG.3C). Generally, at least some features of the shunt136 can be generally similar or identical in structure and/or function to one or more features of the adjusting shunting systems described in U.S. Patent App. Publication No. US 2021/0251806, the entirety of which was previously incorporated by reference herein.

FIGS.8A and8B are perspective views of the shunt136 and a priming interface or assembly870 (“priming assembly870”) configured in accordance with embodiments of the present technology. In some embodiments, the priming assembly870 can be at least generally similar in structure and/or function to, identical in structure and/or function to, and/or otherwise incorporated as part of the shunt coupling member132 (FIG.1C) and/or the push rod432 (FIGS.4B and4C), although in other embodiments the priming assembly870 can be a standalone component or otherwise secured to a portion of the delivery system100,400.

Referring toFIGS.8A and8B together, the priming assembly870 can include a first priming element872aand a second priming element872b,each of which can be configured to be positioned within the outflow channel764 of the shunt136. The first and second priming elements872a,872bcan be configured to form a substantially fluid-impermeable seal when positioned within the outflow channel764. In the illustrated embodiment, for example, one or both of the first and second priming elements872a,872bcan include respective arms or sealing segments873 (individually identified as a first arm873aof the first priming element872aand a second arm873bof the second priming element872binFIGS.8A and8B) sized and/or otherwise configured to have an interference fit with the outflow channel764. Additionally, or alternatively, one or both of the arms873 can include a sealing element (e.g., a seal-forming coating, an O-ring, etc.) and/or another suitable seal-forming configuration. When positioned within the outflow channel764, the substantially fluid-impermeable seal between priming elements872 and the outflow channel764 can be configured to store a vacuum generated within at least a portion of the shunt136, as described previously with reference toFIG.6. Movement of one or both of the first and second priming elements872a,872brelative to one another and/or the shunt136, such as at least partially removing one of the arms873 from the outflow channel764, can disrupt or breach the substantially fluid-impermeable seal formed between the first and second priming elements872a,872band the outflow channel764. One or both of the arms873 can abut the interface portion762 when positioned within the outflow channel764. In some embodiments, one or both of the priming elements872 can include a registration feature874 (individually identified as a first registration feature874aof the first priming element872aand a second registration feature874bof the second priming element872binFIG.8A) configured to position/orient the priming elements872a,872brelative to one another. In the illustrated embodiment, the first registration feature874aincludes a slot or recess and the second registration feature874bincludes tab or projection configured to be positioned within the slot/recess. In other embodiments, the first registration feature874acan include the tab or projection and the second registration feature874bcan include the slot or recess, and/or one or both of the first and second registration features874a-bcan have another suitable configuration.

To prime the shunt136, one of the priming elements872 (e.g., the first priming element872a) is withdrawn at least partially from the outflow channel764, as shown inFIGS.8B and8D, while the other priming element (e.g., the second priming element872b) provides a counterforce against the outflow channel interface762 such that a relative position of the shunt136 (e.g., with respect to the system100,400) is maintained. This movement of one of the priming elements872 can cause fluid (e.g., priming fluid) to be drawn into the shunt136, e.g., via the first portion336a.For example, because the priming elements872 can form a substantially fluid-impermeable seal with the shunt136 when positioned within the outflow channel764, withdrawing one of the priming elements872 can generate a pressure (e.g., a vacuum) within at least a portion of the shunt136 (e.g., the outflow channel764) and cause the generated pressure to be applied to another portion of the shunt136 (e.g., the flow control assembly760) to thereby aspirate or otherwise draw fluid (e.g., priming fluid, aqueous, etc.) into the shunt136. When both of the priming elements872a,872bare positioned within the outflow channel764, the resistance to fluid flow into the shunt is expected to inhibit or prevent fluid low into the shunt. Removing one or both of the priming elements872 can allow fluid (e.g., priming fluid, aqueous, etc.) to enter at least a portion of the shunt136 to reduce resistance to initiating fluid flow through the shunt136, as described previously herein (e.g., with reference toFIG.6). The remaining priming element (e.g., the second priming element872b) can be readily removable with minimal force and/or alteration of shunt's placement. This is described in greater detail below with reference toFIGS.8C and8D.FIG.8C, for example, is a cross-sectional view of the shunt136 and the priming assembly870 taken along line8C-8C inFIG.8A. Referring toFIG.8C, for example, the tab registration feature874bof the second priming element872bis positioned within the slot registration feature874aof the first priming element872a,such that the first priming element872ais positioned between (i) the lateral sides876a,876band upper surface876cof the second priming element872band (ii) the lateral inner sides878a,878band upper inner surface878cof the outflow channel764, respectively.

FIG.8D is a cross-sectional view of the shunt136 and the priming assembly870 taken along line8D-8D inFIG.8B. Referring toFIG.8D, when the first priming element872ais withdrawn from the outflow channel764, the second priming element872bcan be spaced apart the lateral inner sides878a,878band the upper inner surface878cof the outflow channel764 and easier to remove than the first priming element872a,e.g., by virtue of the tab registration feature874bbeing smaller than the recess registration feature874a.

FIG.9 is a perspective view of another priming assembly970 configured in accordance with embodiments of the present technology. At least some aspects of the priming assembly970 can be generally similar or identical in structure and/or function to the priming assembly870 ofFIGS.8A-8D. Accordingly, like name and/or reference numbers (e.g., first and second priming elements972a,972bversus the first and second priming elements872a,872bofFIGS.8A-8D) are used to indicate generally similar or identical aspects. The priming assembly970 differs from the priming assembly870 in that one or both of the first and second priming elements972a,972bcan include multiple registration features974. In the illustrated embodiment, for example, the first priming element972aincludes two recessed priming features974aand the second priming element972bincludes two corresponding protrusion priming features974b.In other embodiments, one or both of the first and second priming elements972a,972bcan include at least three, four, five, or another suitable number of registration features.

EXAMPLES

Several aspects of the present technology are set forth in the following examples:

1. A method for delivering an adjustable shunt to a patient via an implant delivery system, the method comprising:

- causing a priming fluid to enter at least a portion of the adjustable shunt;
- extending the adjustable shunt from within the implant delivery system, wherein extending the adjustable shunt includes actuating a drive assembly of the implant delivery system to move a driven assembly of the implant delivery system along a longitudinal axis of the implant delivery system, and wherein the driven assembly is configured to carry the adjustable shunt; and
- after extending the adjustable shunt from the implant delivery system, positioning the adjustable shunt at a target location within the patient.
  2. The method of example 1 wherein causing the priming fluid to enter at least the portion of the adjustable shunt includes injecting the priming fluid via a priming inlet fluidly coupled to the adjustable shunt.
  3. The method of example 2 wherein injecting the priming fluid includes injecting the priming fluid using a fluid delivery tool and/or a syringe.
  4. The method of example 2 or example 3 wherein injecting the priming fluid via the priming inlet includes injecting the priming fluid via a priming inlet of a cap of the implant delivery system.
  5. The method of any of examples 1-4 wherein causing the priming fluid to enter at least a portion of the adjustable shunt includes creating a pressure gradient between an interior of the adjustable shunt and an exterior of the adjustable shunt.
  6. The method of example 5 wherein creating the pressure gradient includes reducing a pressure within the interior of the adjustable shunt.
  7. The method of any of examples 1-6 wherein causing the priming fluid to enter at least a portion of the adjustable shunt includes causing the priming fluid to enter at least a portion of the adjustable shunt via a vacuum generated within the implant delivery system.
  8. The method of any of examples 1-7, further comprising generating a vacuum within a chamber of the implant delivery system, wherein the adjustable shunt is positioned within the chamber, and wherein causing the priming fluid to enter at least a portion of the adjustable shunt includes drawing the priming fluid into the chamber via the vacuum generated therein.
  9. The method of any of examples 1-8 wherein causing the priming fluid to enter at least the portion of the adjustable shunt includes moving a priming element of a priming assembly positioned at least partially within the adjustable shunt relative to the adjustable shunt.
  10. The method of example 9 wherein moving the priming element includes reducing a pressure within an interior of the adjustable shunt to draw the priming fluid into the adjustable shunt.
  11. The method of example 9 or example 10 wherein moving the priming element includes moving a first priming element of the priming assembly relative to a second priming element of the priming assembly.
  12. The method of any of examples 9-11 wherein moving the priming element includes removing the priming element from an outflow channel of the adjustable shunt.
  13. The method of any of examples 1-12 wherein positioning the adjustable shunt at the target location includes positioning at least a portion of the adjustable shunt posterior to an iris of an eye of the patient.
  14. The method of any of examples 1-12 wherein positioning the adjustable shunt at the target location includes positioning at least a portion of the adjustable shunt anterior to an iris of an eye of the patient.
  15. The method of any of examples 1-14 wherein positioning the adjustable shunt at the target location includes positioning a first portion of the adjustable shunt in a first body region of the patient and positioning a second portion of the adjustable shunt in a second body region of the patient.
  16. The method of example 15, further comprising causing fluid to drain from the first body region toward the second body region.
  17. A priming assembly for an adjustable shunting system, the priming assembly comprising:
- a first priming element; and
- a second priming element,
- wherein the first and second priming elements are configured to be (a) positioned within an outflow channel of the adjustable shunting system and (b) moved relative to one another to cause fluid to enter the adjustable shunting system.
  18. The priming assembly of example 17 wherein the first and second priming elements are movable relative to one another to cause a priming fluid to enter the adjustable shunting system.
  19. The priming assembly of example 17 or example 18 wherein the first and second priming elements are movable relative to one another to cause aqueous to enter the adjustable shunting system.
  20. The priming assembly of example 17 wherein the first priming element includes a first registration feature, and wherein the second priming element includes a second registration feature configured to be positioned at least partially within the first registration feature.
  21. The priming assembly of any of examples 17-20 wherein the first and second priming elements are configured to form a substantially fluid-impermeable seal with the outflow channel.
  22. The priming assembly of example 21 wherein movement of one or both of the first and second priming elements relative to one another disrupts the substantially fluid-impermeable seal.
  23. The priming assembly of example 21 or example 22 wherein movement of one or both of the first and second priming elements relative to one another changes a pressure within an interior of the adjustable shunting system to draw the fluid into the adjustable shunting system.
  24. The priming assembly of any of examples 17-23 wherein the first and second priming elements are configured to contact an interface portion of a flow control assembly of the adjustable shunting system when positioned within the outflow channel.
  25. A delivery system for use with an adjustable shunt for treating a patient, the delivery system comprising:
- a housing including a tip, wherein the tip defines a distal terminus of the delivery system;
- a drive assembly movably coupled to the housing; and
- a driven assembly operably coupled to the drive assembly and configured to (i) be releasably coupled to the adjustable shunt, and (ii) move relative to the housing and cause a corresponding movement of the driven assembly to transition the delivery system between a first state and a second state,
- wherein
  - in the first state, the driven assembly is configured such that the adjustable shunt is completely within the housing, and
  - in the second state, the driven assembly is configured such that at least a portion of the adjustable shunt extends distally beyond the distal terminus of the housing.
    26. The delivery system of example 25 wherein:
- the housing extends along a longitudinal axis;
- the drive assembly is rotatably coupled to the housing;
- the driven assembly is slidably coupled to the housing; and
- the driven assembly is configured to move along the longitudinal axis of the housing in response to rotational movement of the drive assembly.
  27. The delivery system of example 25 or example 26 wherein the drive assembly includes a threaded drive shaft threadably coupled to the housing.
  28. The delivery system of any of examples 25-27 wherein the drive assembly includes an annular protrusion, and wherein the driven assembly includes an annular slot configured to receive the annular protrusion.
  29. The delivery system of example 28 wherein the annular protrusion is configured to rotate within the annular slot such that the driven assembly does not rotate in response to rotational movement of the drive assembly.
  30. The delivery system of any of examples 25-29 further comprising a shunt coupling member configured to releasably couple the adjustable shunt to the driven assembly.
  31. The delivery system of example 30 wherein the shunt coupling member is configured to be positioned at least partially within the adjustable shunt.
  32. The delivery system of example 31 wherein the shunt coupling member is configured to facilitate priming of the adjustable shunt with priming fluid before delivery of the adjustable shunt within the patient.
  33. The delivery system of example 32 wherein the shunt coupling member is configured to cause the priming fluid to enter at least a portion of the adjustable shunt when the shunt coupling member is moved relative to the adjustable shunt.
  34. The delivery system of example 32 or example 33 wherein the shunt coupling member includes a priming assembly, wherein the priming assembly includes a priming element configured to be positioned within an outflow channel of the adjustable shunt.
  35. The delivery system of example 34 wherein the priming element is a first priming element, the priming assembly further comprising a second priming element, wherein the first and second priming elements are movable relative to one another and the adjustable shunt to cause the adjustable shunt to be primed with the priming fluid.
  36. The delivery system of any of examples 25-35, further comprising a priming port configured to fluidly couple the adjustable shunt to a priming fluid source when the adjustable shunt is carried by the delivery system.
  37. The delivery system of example 36, further comprising a cap configured to be releasably coupled to the housing at least partially around the tip, wherein the cap includes the priming port.
  38. The delivery system of example 37 wherein the cap is configured to contain a vacuum generated therein and receive priming fluid drawn from the priming fluid source through the priming port via the vacuum.
  39. The delivery system of any of examples 36-38 wherein the tip includes (i) an opening defining the distal terminus and (ii) the priming port, wherein the priming port is opposite the opening.
  40. The delivery system of any of examples 25-39 wherein the adjustable shunt is an adjustable intraocular shunt configured to be positioned in an eye of a patient.

CONCLUSION

The above detailed description of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology as those skilled in the relevant art will recognize. For example, any of the features of the adjustable shunts described herein may be combined with any of the features of the other adjustable shunts described herein and vice versa. Moreover, although steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions associated with intraocular shunts have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms may also include the plural or singular term, respectively.

Unless the context clearly requires otherwise, throughout the description and the examples, the words “comprise,” “comprising,” and the like are to be construed in an inclusive sense, as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to.” As used herein, the terms “connected,” “coupled,” or any variant thereof, means any connection or coupling, either direct or indirect, between two or more elements; the coupling of connection between the elements can be physical, logical, or a combination thereof. Additionally, the words “herein,” “above,” “below,” and words of similar import, when used in this application, shall refer to this application as a whole and not to any particular portions of this application. Where the context permits, words in the above Detailed Description using the singular or plural number may also include the plural or singular number respectively. As used herein, the phrase “and/or” as in “A and/or B” refers to A alone, B alone, and A and B. Additionally, the term “comprising” is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and/or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with some embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.